左羟丙哌嗪缓释片体外释放度测定  

Determination of dissolution rate of levodropropizine sustained-release tablets

作　　者：鄢琳[1] 李铜铃[1] 张蓉琴[1] 许小红[1] 郑鹏程[1] 胡阳敏[2] 

机构地区：[1]四川大学华西药学院临床药学教研室,成都610041 [2]浙江大学附属第二医院药剂科,杭州310013

出　　处：《中国临床药学杂志》2004年第4期221-224,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的:建立左羟丙哌嗪缓释片体外释放度测定方法,并对其释放度影响因素及释药机制进行考察。方法:采用单因素考察方法,研究处方、工艺及释放方法学因素对左羟丙哌嗪缓释片释放度的影响。结果:左羟丙哌嗪在237nm波长有最大吸收,辅料对药物测定无干扰。左羟丙哌嗪在2.56-20.48 mg·L-1浓度范围内线性关系良好。羟丙甲基纤维素的种类、用量、黏度、片剂的比表面积以及不同释放条件对药物的释放特性有一定影响。结论:左羟丙哌嗪缓释片的释放表现为药物扩散和凝胶溶蚀的协同作用,许多因素可以影响药物释放行为。AIM: To establish the dissolution method of levodropropizine sustained-release tablets and study its release characteristics in vitro . METHODS: Using the single factor studies, the effects of formulation, technological fac-tors and different dissolution methods on the release profiles were investigated. RESULTS: The maximum absorption of levodropropizine was at 237nm and the excipient had no effects on the drug determination. The linear range of levodropropizine was 2.56-20.48 mg·L-1. HPMC type, viscosity, content, area per unit of tablets and different dissolution methods influenced the release characteristics. CONCLUSION: The release of levodropropizine sustained-release tablets is coupled action of diffusion and erosion mechanism, many factors influence the process of drug release.

关 键 词：左羟丙哌嗪缓释片 体外释放度 测定 影响因素 释药机制 

分 类 号：R927.1[医药卫生—药学]